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Rare brain infection risk under scrutiny for multiple sclerosis drug ozanimod

NCT ID NCT07732907

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study investigates whether the multiple sclerosis medication ozanimod is linked to a higher risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection caused by the John Cunningham virus. Researchers will review reported cases of PML in people with MS who have taken ozanimod, looking at factors like age, treatment duration, and prior medication use. The goal is to estimate how often PML occurs and identify who might be most at risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ozanimod
What this could lead to
If successful, this study could help identify which patients with multiple sclerosis are at higher risk of developing PML while on ozanimod, potentially guiding safer prescribing.
What could go wrong
This is a small, observational study based on reported cases, not a controlled trial. It may not capture all cases or prove causation, and the findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2041

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults diagnosed with multiple sclerosis who have been treated with ozanimod and have reported potential progressive multifocal leukoencephalopathy events identified through the Bristol Myers Squibb safety database, spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adverse event (AE) report with MedDRA Preferred Term of " John Cunningham virus (JCV) cerebrospinal fluid test positive", " JCV granule cell neuronopathy", or "Progressive multifocal leukoencephalopathy (PML)" reported to the Sponsor between 4-Jun-2026 and 31-Jul-2041. * AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs. * Diagnosis of multiple sclerosis before the initial AE report. * Exposure to at least one dose of ozanimod before onset of PML symptoms. * PML event assessed as "definite" or "probable" by the adjudication committee. * PML assessed as "related" to ozanimod by the adjudication committee. Exclusion Criteria: • There are no additional exclusion criteria.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis progressive multifocal leukoencephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis Progressive multifocal leukoencephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bristol Myers Squibb

    RECRUITING

    Lawrenceville, New Jersey, 08648, United States

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